1. Master Introduction for the Regulators
Rulemaking
Master
Introduction for the Regulators

2. Jargon Alert Rule, legislative rule, or regulation
They all mean the same thing
Has the same effect as a statute passed by the legislature
Non-Legislative rule
Has no legal effect, but shows what the agency thinks the law is
Many names - interpretive rule, guidelines, guidance document, anything but rule or regulation

3. The Agency as Legislature
The modern rulemaking process got started in the 1950s and really accelerated in the 1970s
Parallels the growth of federal agencies
In theory, the federal courts encourage agency rulemaking.
It reduces litigation and simplifies the litigation that ensues.

4. The Power to Make Rules
The power to make rules must be delegated by the legislature.
If the enabling legislation (the legislation creating an agency) is silent, the agency cannot make rules
The delegation may be broad, allowing the agency great discretion, or very narrow.
We will look at the standards for reviewing this delegation later in the course

5. Notice-and-Comment Rulemaking
APA Procedures
The Register
The Federal Register
LA Register
Electronic Notice

6. Why Have Public Participation?
Public participation has great political benefit in broadening the acceptability of the rules.
Public comments can identify technical and legal problems with the rules
Publication of proposed rules allows politicians to become involved to protect the interests of their constituents
Public participation limits executive power and makes it more palatable to the courts to have agencies making laws
While the agency may take comments at public hearings, it is usually done in writing.

7. Attacking Rulemaking
Once a rule has been properly promulgated through notice and comment, it can only be attacked by attacking the published basis for the rule, and that must be done relatively soon after promulgation.
We will see in the movie how the opponents of the rule work to get their changes made before the rule is finished.

8. Part II – Introduction to Non-Legislative Rules
Rulemaking
Part II – Introduction to Non-Legislative Rules

9. Rule or Adjudication?

10. Londoner v. City and County of Denver, 210 U.S. 373 (1908)
The City of Denver paved the road in front of plaintiff’s property. Under the law at that time, property owners were liable for the cost of such improvements.
Plaintiff’s individual assessment was based on specific factors about this property.
The court found that plaintiff was entitled to present evidence and be heard on his objections to facts on which his assessment was based.
This hearing is an adjudication.

11. Bi-Metallic Investment Co. v. Colorado, 239 U.S. 441 (1915)
The State Board of Equalization determined that property was undervalued in Colorado and imposed a rule that all evaluations be increased by 40%.
This was not a reevaluation of each piece of property, but a uniform and mechanical increase in the individually determined valuations.
The court found that there is no right to a hearing for rules of general applicability.

12. Must the Agency Make Rules?
If the agency has the power to make rules, it has the discretion on what rules to make and when to make them.
The legislature can put provisions in the agency legislation requiring that certain rules be made, and the timeframe for making them.
The Clean Air Act required rulemaking to flesh out detailed technical standards
Unless there is a legislative directive, it is difficult to get the courts to force an agency to make rules
Not impossible, as we will see latter.

13. Why Make Rules?
Many statutes have too little detail to be enforced without additional rules.
Rules can be used to tailor a statute to new circumstances.
Rules provide a chance for the for the public to participate in the regulatory process
Once promulgated, a rule in binding on every party, reducing the need for adjudications.

14. Uniformity
Rules set up a general framework that treats all parties uniformly
Rules are the fairest way to make big regulatory changes
If the agency does not have rules, it can change enforcement policy from case to case, and is also at the mercy of judges to accept or reject agency standards

15. Adoption of National Standards
National standards can be adopted through agency rules, harmonizing practice across jurisdictions
National building codes
CDC guidelines on food sanitation
Recommendations of the Advisory Committee on Immunization Practices
LA and building codes

16. Agency Efficiency
While a rulemaking can be expensive and time consuming, it can settle issues which might otherwise have to be litigated in every enforcement case
Rulemaking can also eliminate many hearings by resolving factual questions
In disability cases, rules can be used to establish what constitutes a disability, rather than making it as case by case determination.

17. Agency Oversight
You can control the outcome of rulemaking much easier than that of adjudications
Not dependent on ALJs (administrative law judges)
This especially important in LA
More input from across the agency
Input from the public as well
Directly controlled by agency policy makers

18. How Does the Nature of the Enabling Act Affect Rulemaking?
Very general laws
Limited detail in the statute
Any interpretative rule is likely to been seen as a legislative rule because it will provide more limits than the statute.
Very specific laws - like the ADA
No room for legislative rules
Everything is guidance

19. The Politics of Rulemaking
Congress often dodges the hardest issues and leaves them to agency rulemaking
Most of these involve cost-benefit analysis
How do you trade off automobile safety with price and fuel efficiency?
Are you more worried about delaying the entry of new drugs or the about allowing the sale of a drug with dangerous side-effects?
Do you want cheap power at the cost of lots of asthma and the Grand Canyon full of smoke?

20. Downside of Rulemaking
Trials (adjudications) involving single parties can be more flexible in the individual cases
Adjudications are useful when you are not sure what the rule should be and need more info and a chance to experiment
Rules can be so abstract or overbroad that they are expensive or difficult to follow
Like statutes
Agencies can promulgate rules that Congress would never pass - Green House Gas Regulations.

21. Rulemaking Ossification
The courts and legislatures have increased the burden on rulemaking, especially in states
Rulemaking has gotten so complex and time consuming it has lost some of its value
Complicated by regulatory conflict and incompetent agency practice
Rulemaking can go on for years
What is the legal value of a proposed rule that has not been finalized?
The Medicare anti-kickback regulations were delayed for years between the proposed rule and the final rule

22. Definition of a Rule APA 551(4)
(4) 'rule' means the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency and includes the approval or prescription for the future of rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances, services or allowances therefor or of valuations, costs, or accounting, or practices bearing on any of the foregoing;
Not a clear definition
Things that are not adjudications or licensing

23. LA Definition
6) "Rule" means each agency statement, guide, or requirement for conduct or action, exclusive of those regulating only the internal management of the agency and those purporting to adopt, increase, or decrease any fees imposed on the affairs, actions, or persons regulated by the agency, which has general applicability and the effect of implementing or interpreting substantive law or policy, or which prescribes the procedure or practice requirements of the agency.
"Rule" includes, but is not limited to, any provision for fines, prices or penalties, the attainment or loss of preferential status, and the criteria or qualifications for licensure or certification by an agency. A rule may be of general applicability even though it may not apply to the entire state, provided its form is general and it is capable of being applied to every member of an identifiable class. The term includes the amendment or repeal of an existing rule but does not include declaratory rulings or orders or any fees.

24. Functional Definitions
General applicability, as opposed to specific parties
Prospective
Binding on the agency as well as on the public

25. Orders versus Rules
Rules are directed to the universe of regulated parties, not to individuals.
Agency directives to specific parties based on individual facts are called orders. They may trigger a hearing for the individual, but do not need notice and comment.
Assume the EPA makes a rule that applies to copper smelters which are located more than 5,000 above sea level.
What is there is only one?
Is this still a rule?
Do we see statutes directed at single parties?

26. APA Rules Must have “Future Effect”
In Bowen v. Georgetown University Hospital, 488 U.S. 204 (1988), HHS changed the reimbursement rules for care that had already been rendered.
Why is that problem for a rule?
Can Congress fix this or is it a constitutional issue?
Can there be retroactive laws?
Superfund?

27. The Effect of a Rule in an Adjudication
The FCC is concerned that concentrated ownership of TV stations is not in the public interest.
Licensing is an adjudication, i.e., the applicant is entitled to a hearing if his license is turned down.
The FCC issues a rule that no one can own more than five stations.
Does an applicant with 5 stations get a hearing when he is turned down based on the rule?
Why or why not?
United States v. Storer Broadcasting Co., 351 U.S. 192 (1956)

28. Do You Have to Have Notice and Comment?

29. Why Avoid Notice and Comment?
Notice and comment is time consuming and subject to long judicial delay.
What is the risk to the agency if it issues guidance without notice and comment, and the court finds the guidance to be a rule requiring notice and comment?
What is the benefit to the regulated parties of interpretive rules and guidance?
What if the agency is prevented from providing guidance documents?

30. Exemptions to Notice and Comment Requirements (does 553 apply at all?)
§ 553. Rule making
(a) This section applies, according to the provisions thereof, except to the extent that there is involved -
(1) a military or foreign affairs function of the United States; or
(2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.

31. Military and Foreign Affairs
Limiting the term of residence for Iranian nationals after the hostage incident
Extending asylum to persons subject to reproductive restrictions in China
Deporting young Muslin men with visa problems.
Changing international trade rules
Why exempt these?

32. Public Property
(2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.
This would exempt Social Security benefits, everything to do with public lands, and many other areas of regulation.
As the regulatory state developed, there was pressure to repeal this provision.
To defuse this, agencies adopted rules requiring notice and comment rulemaking in several of these areas.
Congress has suspended this section in many enabling laws.
You have to look at the agency’s own rules and enabling act to see if 553 has been waived.

33. 553(b) – [General] Exceptions to Notice Requirements
1) Interpretative rules, general statements of policy, and rules of agency organization, procedure, and practice; and
2) Rules when the agency finds for good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.
No notice means no comment under 553(c)

34. Legislative and Nonlegislative Rules
Agencies can only make legislative rules if the legislature delegates this power to the agency through statute.
Nonlegislative rules (guidelines, etc.) do not have legal effect. They only explain the agency’s view of the law.
Does an agency need statutory authorization to issue non-legislative rules?

35. Can Nonlegislative Rules be Retroactive?
Why does the ban on retroactive rules not apply to interpretive rules?
How do judges change the law retroactively?
If interpretive rules cannot change legal rights, does retroactive really mean anything for nonlegislative rules?

36. Exception 1 - Interpretative Rules
It is only explaining the law or providing guidance for action
Prosecution guidelines
IRS audit guidelines
Since they do not change the law, they have no legal effect
Like commentary in the civil law?
Does that mean you can ignore them?

37. EPA Example – Is This Definition a Rule?
EPA says that the term “waters of the United States” (which defines the jurisdiction of EPA under the Clean Water Act) includes wetlands that potentially provide habitat to migratory birds.
This might include a pothole in a field, not otherwise connected to a waterway.
If the EPA has jurisdiction over the wetland, it will become expensive or impossible to drain or develop the area.

38. Is this an Interpretative Rule or a Legislative Rule?
Can we tell by just looking at the rule?
How might this definition affect the value of the wetlands?
Is this a “substantial impact”?
Assuming that it is a substantial impact, how can the agency defend not using notice and comment?
The substantial impact test has now been mostly abandoned in favor of the “legally binding” test.

39. The “Legally Binding” or “Force of Law” Test
Can the agency enforce the law without the rule?
Continuing with the previous wetlands example
Is the agency required to define wetlands before enforcing the statute?
Was the agency doing enforcement before this rule?
If so, does this change the enforcement?
What does tell us about whether it is legally binding?
Assume a statute allows the agency to define toxic substances that cannot be dumped into lakes.
Would a list of these substances need notice and comment?
Could the law be enforced without the list?

40. How High do I Build the Fence. Hoctor v. USDA, 82 F. 3d 165 (7th Cir
Statute requires the agency to adopt rules for the safe housing of dangerous animals
Agency uses notice and comment to promulgate a rule requiring that reasonable precautions be taken to prevent the escape of the animals
Agency then issues guidance saying that a reasonable precaution would be an 8 foot fence.
Interpretation or legislation?
How does it change the proof of facts in the enforcement adjudication?

41. Junk in the Park: United States v. Picciotto, 875 F. 2d 345 (D. C. Cir
Can the agency use notice and comment to promulgate a legislative rule that says that the agency can add other requirements in specific situations without notice and comment?
Why or why not?
What if the rule just says that nothing can be brought to the park that would be disruptive or impede public access?
Would it need a specific list?
How does not having a rule affect enforcement?

42. Inconsistent with a Rule: Phillips Petroleum Co. v. Johnson, 22 F
Inconsistent with a Rule: Phillips Petroleum Co. v. Johnson, 22 F.3d 616 (5th Cir. 1994).
An agency cannot issue a rule that is inconsistent with a statute, and thus it certainly cannot issue guidance that is inconsistent with the statute.
What about guidance that is consistent with the statute, but not with a rule based on the statute?
This would change the rule without notice and comment.

43. Non-Procedural Indicators
Saying it is guidance/interpretative rule.
Publication in the Code of Federal Regulations (CFR).
Does the person signing the document have the authority to make a rule?

44. General Policy Statements and Procedural Rules

45. Agency Procedures Like the code of civil procedure
Does not change the substantive rights of the parties
Does not change the regulated behavior, only the process in agency procedures
Thus no need for public participation.

46. General Policy or Specific Requirements?
Remember, 553(b) does not require notice and comment for general policy statements or procedural rules.
Assume the statute says that in licensing actions, a physician must reply to agency request for information in a reasonable time.
How would you argue that a 7 day answer period is a substantive change, not just a procedural requirement?
Why does the inclusion of specific factual information (deadline periods, fence heights) undermine the claim that it is a general policy statement?

47. Federal Mine Safety and Health Act Example
Secretary has the statutory right to sue both the mine owner and the mine operator for violations of the Act.
Secretary publishes a policy statement explaining that the agency can and will sue both of them for infractions, depending on the nature of the infraction.
Does this require notice and comment?
Why?

48. Enforcement Manual
The Coast Guard is authorized to investigate and enforce against certain types of oil pollution in the waters of the United States under the Clean Water Act.
To aid its officers engaged in these functions it has created a Marine Safety Manual.
That Manual gives guidance as to what appropriate penalties might be for various types of pollution incidents.
The range of penalties is specified in statutes.
Legislative rule or prosecution policy?
What is the key?

49. Corps of Engineers Example
Corps issues a guidance document providing examples of ways to mitigate wetlands damage.
One way is to promise to restore 2X as much wet land as you fill.
Does this need notice and comment?
Why or why not?
What if the Corps will only issue permits to people who agree to this?
How would you prove this?

50. Setting a Threshold for Prosecution
The FDA issues a policy statement that it will not take enforcement actions against candy bars unless they have more than 5 insect parts per bar.
There is no statutory standard.
You represent Consumers Disgusted by Bug Parts, Inc.
What is your argument that this is really a rule?
Community Nutrition Institute v. Young, 818 F.2d 943 (D.C. Cir. 1987)

51. Coercion: Chamber of Commerce v. U. S. DOL, 174 F. 3d 206 (D. C. Cir
DOL made a policy statement that it would reduce inspections of workplaces that adopted an OSHA suggested safety plan that exceeded federal minimums
Is this really voluntary?
What happens if you do not comply?
Does coercion make this a binding rule?
What about DOJ guidance that a corporate compliance plan will count as mitigation under the Sentencing Guidelines?
Does it affect law abiding companies?

52. Substantial Impact Test for Procedural Rules
The Department of Health and Human Services changed the method by which home health providers could obtain reimbursement for expenses under the Medicare Program. In particular it required that they submit their requests in a new format and to regional intermediaries, rather than to HHS directly.
How did plaintiffs argue that this was a legislative rule, rather than a procedural rule?
What is the impact on them of the change?

53. Inspection or Prosecution Guidelines
OSHA adopts a plan for deciding which employers to inspect.
A selected employer contests the rule, saying that OSHA inspections are expensive and time consuming, thus this has a substantial impact.
Is this a successful argument?
Why, or why not?
How is this different from the coercion case?

54. Procedural Rules and Policy Statements – Wrap-up
Same analysis as substantial impact or legally binding test for substantive rules.
What is the actual impact on your client?
Will compliance costs significantly increase – Medicare case?
Does it change their legal options – shortened period to reply to complaint?
Does it actually change substantive requirements – requiring new information for a benefit determination?
We will revisit this when we look at standing.

55. Publishing Legislative Rules that do not need Notice and Comment
APA 552(D) Publication in the FR
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
What if the agency does not publish the document in the FR, but puts it on the Internet? (Which has become very common.)
“Except to the extent that a person has actual and timely notice of the terms thereof...”

56. Interpretive Rule or Legislative Rule Wrap Up
Does it force regulated parties to change their actions?
Does the agency treat it as binding?
Does it allow exceptions?
Is it necessary to enforce the statute?
List of pollutants, for example.
Does it provide specific details which limit the action of regulated parties?

57. Notice and Public Procedures Are Impracticable, Unnecessary, or Contrary to the Public Interest

58. Actions where Secrecy is Important
Wage and price controls
Bidding on contracts
Negotiations on land purchases and sales

59. Emergencies and Impracticality
Emergency Rules
Misused in LA
This GAO Report indicates that the feds may also misuse this exception.
Interim Final Rules
Published and in effect, but will be modified after comments are in.

60. Time Constraints
The GAO found that agencies frequently skip notice and comment when they have to make a rule with a short timeframe.
Usually statutory deadlines, or a version of emergencies.
Classic would be hunting seasons.
How would this have helped in the Regulators?
How did notice and comment improve the rule?
Should the agency be able to use this exception if has delayed rulemaking?

61. Technical Corrections
Calculations and other non-discretionary rules
Technical corrections
Can require notice and comment if the correction causes a different result.
Theory is that these are mechanical and thus notice and comment would not add any new information.

62. What is Formal Rulemaking?
A rulemaking conducted as a trial type hearing
The agency support for the rule must be presented at the hearing
Interested parties may present and cross-examine evidence
History - grew out of rate making in the early 20th century.
Rate making affects a small number of parties
The courts thought they should get due process

63. Why avoid formal rulemaking?
The peanut hearings (FDA must do formal rulemaking in some situations)
Should peanut butter have 87 or 90% peanuts?
10 years and 7,736 pages of transcript
What was the concern in Shell Oil v. FPC?
Formal rulemaking was impossibly time consuming to use for regulating something changeable such as natural gas rates.
Why does just getting the right to be heard at a formal hearing benefit parties that oppose a rule?

64. When is Formal Rulemaking Required?
Disfavored by the modern courts
Must have magic statutory language or be required by the agency's on rules
Only when rules are required by statute to be "made on the record after opportunity for an agency hearing"
Lawyering tip
When would you want to argue that formal rulemaking is required?
What do you have to do to support your request?

65. When Do You Need To Re-Notice a Revised Rule?

66. Chocolate Manufacturers Ass’n v. Block, 755 F.2d 1098 (4th Cir. 1985)
What is WIC?
What evil substance in what food did the proposed rules propose to regulate?
How was the final rule different from the proposed rule?
What new product was regulated?

67. The Notice Problem What was the CMA's claim?
What was the agency defense?
Does the rule have to be the same?
Why have notice and comment then?
What is the logical outgrowth test?
How would you use it in this case?
What did the court order in this case?
What will the CMA do if a new proposed rule includes them?

68. Limits on Logical Outgrowth - Arizona Public Service Co. v. E.P.A.
EPA publishes a proposed rule that gives Indian tribes the same regulatory rights as states.
State plans are subject to state court judicial review
Why did the tribes object to this in comments?
How was the rule changed?
What was the claim by plaintiffs?
How did the court analyze the problem?
Why shouldn't the change have been a surprise?

69. What about Technical Information Underlying the Rule? (not in book)
Portland Cement v. Ruckelshaus, 486 F2d 375 (1973)
The agency must disclose the factual basis for the proposed rule, if it relied on scientific studies or other collections of information.
Connecticut Light and Power v. NRC, 673 F2d 525 (1982)?
The agency cannot hide technical information.
Why is this a big deal in environmental regs?
What are the potential downsides of this policy?

70. Additions to the Published Record
(not in book)

71. Rybachek v EPA, 904 F.2d 1276 (1990) Gold mining under the CWA.
In a dubious reincarnation of the 1890's world of Yukon poet Robert Service, we deal here a century later with “strange things done in the midnight sun by the men who moil for gold.”, quoting The Cremation of Sam McGee
EPA added 6000 pages of supporting info when responding to comments
The agency may supplement the rulemaking record in response to comments asking for explanation.

72. Idaho Farm Bureau Federation v. Babbitt, 58 F.3d 1392 (9th Cir. 1995)
Endangered Species Act listing.
Agency added a report to the record when it replied to comments, then relied on it in the final rule.
The agency may not add new material and then rely on it without given an opportunity to comment on it.

73. Rulemaking
Part III

74. Negotiated Rulemaking

75. Negotiated Rulemaking
What is this?
Why is often used in environmental rulemaking?
What are the advantages?
What are the public participation issues?
Assume you are regulating wood stoves
Which groups are most likely to be able to participate?

76. Negotiated Rulemaking and Notice and Comment
The negotiation happens before the rule is proposed in the FR.
The standards for publication and notice are the same as for all other notice and comment rules.
This solves any ex parte contacts problem because the rule must be fully justified by its published record.
Interested parties can still comment.

77. Ex Parte Communications in Litigation
What is an ex parte communication in litigation?
Why do we ban them in litigation?
If a party in a lawsuit wants to talk to the judge, how are ex parte contacts avoided?

78. Ex Parte Communications in Rulemaking
How does the notice provision in rulemaking change the issues in ex parte communications?
Why aren’t ex parte communications before the promulgation of the rule a problem?
When could ex parte communications be an issue?
How can you cure this?
The key is whether the published record supports the rule.

79. Bias and Prejudice
Why do we worry about bias and prejudice in litigation?
What was the trade off in adjudication, where we accept potential sources of bias that would not be acceptable in an Article III trial?
How does the process of rulemaking minimize the bias and prejudice problem?

80. Association of National Advertisers , Inc. v. FTC, 627 F.2d 1151 (D.C. Cir. 1979)
FTC is adopting rules on TV advertising directed at children.
Chairman has written and spoken at length on the evils of TV ads aimed at children
Plaintiffs seek to disqualify him because of bias
Court held that plaintiffs must show clear and convincing evidence that he has an unalterably closed mind on matters critical to the rulemaking
No rulemaking has ever been overturned on the basis that a decisionmaker was unlawfully prejudiced.

81. Sierra Club v. Costle, 657 F.2d 298 (D.C. Cir. 1981)
Rulemaking on coal fired power plants
Why is this controversial then and more so now?
Plaintiffs claimed that the president influenced the agency decision after the comment period.
Is that wrong?
Senator Bird also weighed in
What do plaintiffs need to show to establish undue influence?
Why is the outcome test, combined with the record, a good solution?

82. What is the President's Role in Rulemaking? (not independent agencies)
Controls and supervises executive branch decisionmaking
Traditionally expressed through OIRA/OMB
How is the role different in adjudications and executive orders?
When should the president's contacts be documented?
When the statute requires that they be docketed
If the rule is based on factual information that comes from such a meeting.

83. Congressional Mandates (Hybrid Rulemaking) at the FTC
issue an advance notice of proposed rulemaking, which describes the area of inquiry under consideration and invites comments from interested parties;
send the advance notice and, 30 days before its publication, the notice of proposed rulemaking to certain House and Senate committees;
hold a hearing presided over by a hearing officer at which persons may make oral presentations and in certain circumstances to conduct cross-examination of persons;
include a statement of basis and purpose to address certain specified concerns;
and conduct a regulatory analysis of both the proposed and final rules that describes the proposal and alternatives that would achieve the same goal and analyzes the costs and benefits of the proposal and the alternatives.

84. Should State Procedures Mirror Federal?

85. Should State Rules Differ from Federal Rules on Notice and Comment?
Limited staff
Greater reliance on the expertise of board members, rather than staff
Board may hear lots of testimony and review a lot of info - they cannot afford the time and effort to put together volumes of supporting info for regs
What about LA's 300+ tiny boards?
Should state agencies have a reduced publication requirement?
Should they be able to publish rules without explanation and only have to explain if asked?

86. Executive Review of Rulemaking

87. Executive Orders Regulating Rulemaking
What is the president's authority over rulemaking?
What about for independent agencies?
Why should the president (ORIA) exercise authority over rulemaking?
Coordination of agencies?
Assuring that the agencies carry out the administration's objectives?

88. Acronyms OMB - Office of Management and Budget
OIRA - Office of Information and Regulatory Affairs

89. Executive Orders on Rulemaking
E.O —Governmental Actions and Interference with Constitutionally Protected Property Rights—Requires agencies when they issue rules with significant takings implications to discuss and identify the takings issues in their submissions to OMB.
E.O —Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations—Requires agencies when practicable and appropriate to translate public documents relating to human health or the environment for limited- English-speaking populations.
E.O —Civil Justice Reform—Requires agencies to review any rules they issue to assure that they do not unduly burden the federal court system.

90. Executive Orders on Rulemaking
E.O —Protection of Children from Environmental Health Risks and Safety Risks—Requires agencies when they issue economically significant rules that concern health or safety risks that may disproportionately affect children to evaluate specifically the environmental or safety effects of the regulation and to explain why the planned rule is preferable to other alternatives.
E.O —Federalism—Requires agencies when they issue rules that impose substantial costs on state and local governments to consult with state and local officials early in the process and to publish in the preamble a description of the agency’s consultation, the nature of their concerns, the need for the rule, and the extent to which the officials’ concerns have been met.

91. Executive Orders on Rulemaking
E.O —Consultation and Coordination with Indian Tribal Governments—Requires agencies to coordinate and consult with Indian tribes when they issue rules that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
E.O —Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use—Requires agencies to prepare a Statement of Energy Effects with regard to significant regulatory actions that are either likely to have a significant adverse effect on the supply, distribution, or use of energy or designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.
E.O —Proper Consideration of Small Entities in Agency Rulemaking—Requires agencies to provide draft rules to the Chief Counsel for Advocacy in the Small Business Administration and to give ‘‘every appropriate consideration’’ to the Chief Counsel’s comments.

92. E.O —Improving Regulation and Regulatory Review— Elaborates five new principles to guide regulatory decisionmaking.
First, agencies are directed to promote public participation, in part through making relevant documents available on regulations.gov to promote transparency and comment. It also directs agencies to engage the public, including affected stakeholders, before rulemaking is initiated.
Second, agencies are directed to attempt to reduce ‘‘redundant, inconsistent, or overlapping requirements,’’ in part by working with one another to simplify and harmonize rules.
Third, agencies are directed to identify and consider flexible approaches to regulatory problems, including warnings and disclosure requirements. Such approaches may ‘‘reduce burdens and maintain flexibility and freedom of choice for the public.’’
Fourth, agencies are directed to promote scientific integrity.
Fifth, and finally, agencies are directed to produce plans to engage in retrospective analysis of existing significant regulations to determine whether they should be modified, streamlined, expanded, or repealed.

93. The Big One - Executive Order 12866
OIRA must review rules that have an impact of more than 100M aggregate or substantial impact on a segment of the economy or any thing else.

94. The Regulatory Philosophy
Federal agencies should promulgate only such regulations as are required by law, are necessary to interpret the law, or are made necessary by compelling public need, such as material failures of private markets to protect or improve the health and safety of the public, the environment, or the well-being of the American people. In deciding whether and how to regulate, agencies should assess all costs and benefits of available regulatory alternatives, including the alternative of not regulating.

95. CBA under 12866
Costs and benefits shall be understood to include both quantifiable measures (to the fullest extent that these can be usefully estimated) and qualitative measures of costs and benefits that are difficult to quantify, but nevertheless essential to consider.

96. Choosing Among Alternatives
Further, in choosing among alternative regulatory approaches, agencies should select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach.
Pretty simple? :-)

97. What must the agency provide OIRA - I
An assessment, including the underlying analysis, of benefits anticipated from the regulatory action (such as, but not limited to, the promotion of the efficient functioning of the economy and private markets, the enhancement of health and safety, the protection of the natural environment, and the elimination or reduction of discrimination or bias) together with, to the extent feasible, a quantification of those benefits;

98. What must the agency provide OIRA - II
An assessment, including the underlying analysis, of costs anticipated from the regulatory action (such as, but not limited to, the direct cost both to the government in administering the regulation and to businesses and others in complying with the regulation, and any adverse effects on the efficient functioning of the economy, private markets (including productivity, employment, and competitiveness), health, safety, and the natural environment), together with, to the extent feasible, a quantification of those costs;

99. What must the agency provide OIRA - III
An assessment, including the underlying analysis, of costs and benefits of potentially effective and reasonably feasible alternatives to the planned regulation, identified by the agencies or the public (including improving the current regulation and reasonably viable nonregulatory actions), and an explanation why the planned regulatory action is preferable to the identified potential alternatives.

100. 12866 and Rulemaking
Why is there a special provision for analyzing impact on small businesses?
Does an executive order create private rights, i.e., can you challenge an agency's OIRA showing in court?

101. Where does the Court Stand on Requiring CBA? (Not in the book.)
The enabling act is controlling, in theory.
In AFL-CIO v. API, 448 U.S. 607 (1980), the court found that OSHA enabling act required CBA on standards for benzene
In American Textile Mfrs. Institute v. Donovan, 452 U.S. 490 (1981), the court found that OSHA did not have to do CBA because it was not required by the statute
Can the agency do CBA even if not required to?
The court increasingly imposes something that looks like CBA during hard look, even if the statute is silent.

102. How do these CBA and Review Requirements Affect Agencies?
What are the effects on the agency?
Fewer rules?
Better documented rules?
Less regulation?
More danger to the public?
Who benefits?
Who loses?
What is the financial impact?

103. Statutory Requirements
National Environmental Policy Act (NEPA) imposes requirements if the rule affects the environment
Regulatory Flexibility Act - small business
Only direct effect on small business
Rules on small truck standards might affect small business owners, but since it is directed at manufacturers, small business owners do not have standing
Paperwork Reduction act - every rule that requires reporting must be reviewed
CDC newsletter cannot ask for reader feedback
Statutory requirements can create private rights

104. Information Quality Act
Requires OMB to adopt guidelines ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies
Why is this a redundant requirement?
What could be the purpose of this requirement?

105. Unfunded Mandates
Unfunded Mandates Act of Agency must do a CBA if the costs exceed 100M
What is an unfunded mandate?
This will be a huge issue in the 2 for 1 EO.
What would be the impact of banning unfunded mandates?
What are the types and impact of unfunded mandates on public schools?

106. Congressional Review Act
Most rules, including those exempt from notice and comment, must be reported to Congress, which has 60 days to review them
There is a provision for emergency rules
What can Congress do if it does not like the rule?
When is this likely to happen?
What about independent agencies?
Why does this law not violate separation of powers?